Objectives: To demonstrate the efficacy of care transition holistic intervention (Multilevel Guided Discharge Planning, MGDP) in reducing 30-day adverse outcomes among frail older patients with acute heart failure (AHF) discharged from Emergency Departments (EDs) and to validate the results of MGDP in real life. Method: Investigators will select frail patients ≥70 years with primary diagnosis of AHF discharged from EDs. The intervention will consist of MGDP implementation: 1) checklist that includes clinical recommendations and resources activations; 2) scheduling of early visit with the specialist; 3) communication with primary care; 4) providing a written instruction sheet to patient or caregiver. Phase 1: matched-pair cluster randomized clinical trial. EDs were randomly allocated to intervention (n = 10) or control (n = 10) group. Investigators will compare the outcomes between intervention and control groups. Phase 2: a quasi-experimental study. The 20 EDs will carry out the intervention. Investigators will compare the outcomes between phase 1 and phase 2 of intervention group and between phase 1 and phase 2 of control group. The main outcome is a 30-day composite endpoint (ED revisit or hospital admission for AHF and cardiovascular death) after being discharged.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
1,260
Clinical recommendations and resources activations + scheduling of early visit with the specialist + communication with primary care + written instruction sheet to the patient
Standard of care
Hospital Clinico San Carlos
Madrid, Spain
RECRUITING30-day emergency revisit or hospital admission for acute heart failure or cardiovascular mortality rate after discharge
The proportion of patients who have emergency revisit or hospital admission for acute heart failure or cardiovascular mortality within 30 days after discharge
Time frame: at 30 days post-discharge
All-cause emergency revisit rate
The proportion of patients who have ED revisit for all causes within 30 days after discharge
Time frame: at 30 days post-discharge
Acute heart failure emergency revisit rate
The proportion of patients who have ED revisit for acute heart failure within 30 days after discharge
Time frame: at 30 days post-discharge
Cardiovascular emergency revisit rate
The proportion of patients who have ED revisit for cardiovascular event within 30 days after discharge
Time frame: at 30 days post-discharge
All-cause hospitalisation rate
The proportion of patients who have an hospitalisation for all causes within 30 days after discharge
Time frame: at 30 days post-discharge
Acute heart failure hospitalisation rate
The proportion of patients who have hospitalisation for acute heart failure within 30 days after discharge
Time frame: at 30 days post-discharge
Cardiovascular hospitalisation rate
The proportion of patients who have hospitalisation for cardiovascular events within 30 days after discharge
Time frame: at 30 days post-discharge
All-cause mortality rate
The proportion of patients who have all-cause mortality within 30 days after discharge
Time frame: at 30 days post-discharge
Cardiovascular mortality rate
The proportion of patients who have cardiovascular mortality within 30 days after discharge
Time frame: at 30 days post-discharge
Free-hospitalization survival
Number of days alive out of the hospital
Time frame: at 30 days post-discharge
Functional impairment (assessed by self-reported Barthel index)
Barthel index measures the subject's capacity to perform ten activities of daily living (feeding, bathing, grooming, dressing, bowel and bladder control, toileting, chair transfer, ambulation and stair climbing). The sum score ranges from 0 (totally dependent) to 100 (totally independent).
Time frame: Change from baseline to 30 days post-discharge
Pharmacological adherence (assessed by Morisky Medication Adherence Scale)
The four-item MGLS measures pharmacological adherence. The score ranges from 0 (perfect adherence) to 4 (some level of non-adherence).
Time frame: Within 30 days after discharge
Satisfaction of patient or caregiver about transition of care (assessed by Care Transitions Measure questionnaire)
CTM questionnaire assesses the quality of care transitions, with lower scores indicating a poorer quality transition, and higher scores indicating a better transition.
Time frame: Within 30 days after discharge
Quality of live of patients (assessed by EuroQol-5D)
EQ-5D measures of health-related quality of life. The descriptive system comprises 5 dimensions (mobility, self care, usual activities, pain/discomfort, anxiety/depression) and each dimension has 5 levels (no problems, slight problems, moderate problems, severe problems, and extreme problems). The EQ VAS records the respondent's self-rated health on a 20 cm vertical, visual analogue scale with endpoints labelled 'the best health you can imagine' and 'the worst health you can imagine'.
Time frame: Within 30 days after discharge
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